bioAffinity publishes clinical framework for CyPath Lung nodule testing

bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) has published a clinical review and white paper outlining specialty-specific protocols for using its CyPath® Lung test in pulmonary nodule evaluation and cancer surveillance.

The paper, authored by Chief Medical Officer Gordon H. Downie, MD, PhD, is titled "Lung Nodules, Lung Microenvironment, Predictive Models and Clinician Risk Stratification Using CyPath® Lung Testing for Early Diagnosis of Lung Cancer." It proposes clinical pathways for three care settings: primary care practices managing incidentally discovered pulmonary nodules, pulmonary nodule and interventional pulmonology programs evaluating patients for biopsy, and oncology practices conducting surveillance of cancer survivors.

The publication draws on three years of commercial experience since CyPath® Lung entered the market. The test analyzes sputum collected from the lungs, using flow cytometry and artificial intelligence to identify porphyrin-labeled cells associated with malignancy. The paper notes that this approach differs from blood-based diagnostics by providing data from the lung microenvironment directly.

"The objective is not to replace clinician gestalt or existing guidelines, but to provide an additional data point when clinical findings are uncertain or contradictory," Dr. Downie said in a statement.

The paper also reviews existing predictive models and includes clinical case studies in which CyPath® Lung was used alongside imaging and other assessments in cases where findings were conflicting or uncertain.

According to a previously published clinical trial cited in the press release, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and a 99% negative predictive value in detecting lung cancer among high-risk patients with small indeterminate lung nodules under 20 millimeters. CyPath® Lung is marketed as a Laboratory Developed Test and is not intended for use as a sole diagnostic tool.

CyPath® Lung is marketed through Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.

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